Bacterial infections are becoming a greater danger. Certain bacteria have become resistant to antibiotic treatment, in some cases to a number of antibiotics, either naturally or through genetic manipulation. Septicemia is now among the most common causes of death in the United States of America (13th as of the year 2000), accounting for over ten billion dollars annually in health care costs. Fatality rates for septicemia are around 20%, totaling over 50,000 deaths annually.
In some cases a bacterium infects a person in a manner that makes any infection dangerous. Inhalation anthrax (bacillus anthracis) infection can be such a case. If inhaled, anthrax spores can cause a set of non-specific symptoms (malaise, fatigue, myalgia, and fever) that do not lead to a clinical diagnosis of anthrax infection, absent actual knowledge of an anthrax exposure having taken place. The spores are deposited in the alveolar spaces and transported to mediastinial lymph nodes by lymphatic action. Once in the nodes, the spores can transform to vegetative cells. With germination, disease follows rapidly into a severe peripheral bacterial infection.
Replicating bacterium can release toxins that lead to necrosis, edema, and hemorrhage. (For the purposes of the present invention, toxins can also refer to any factors that lead to an actual toxin, such as anthrax edema factor (EF a 89 kD adenylate cyclase protein) that leads to edema toxin (ET) if combined with anthrax protective antigen (PA, a 83 kD cell binding component) or anthrax lethal factor (LF, a 90 kD metalloprotease) which leads to lethal toxin (LT) if combined with PA.) At this point, diagnosis typically does not save the patient. In fact, antibiotic treatment may actually cause a crisis in the blood that leads to death, by killing the infecting bacteria, and thereby releasing a flood of toxins to the peripheral system, a toxin overload.
Extracorporeal devices have been used in the past, but not for treating patients for severe peripheral bacterial infections. For example, U.S. Pat. No. 6,039,946 to Strahilevitz discloses an extracorporeal affinity adsorption device for providing therapeutic intervention. The container contains a chelant for binding metal ions in the blood and an antibody specifically binding to either an anti-cancer drug or a combined anti-cancer drug/targeting antibody.
Extracorporeal devices have also been disclosed for use in the treatment of retroviral diseases such as HIV infection; U.S. Pat. No. 4,824,432 teaches about a container that has a means for removing interferon or HIV virus.